It’s no secret that opioid overdoses are a problem in American society—especially in the age of fentanyl. The number of deaths due to drug overdose has continuously risen over the past 2 decades, with 91,799 logged in 2020 and 106,699 in 2021, compared with fewer than 20,000 in 1999.

National Institute on Drug Abuse. Drug Overdose Death Rates. June 30, 2023.

 

 

In late March 2023, the FDA issued a press release announcing the approval of naloxone nasal spray (Narcan) as the first OTC opioid overdose treatment in a bid to decrease the number of overdose deaths, which are chiefly driven by illicit opioids.

US Food and Drug Administration. FDA Approves First Over-the-Counter Naloxone Nasal Spray [press release]. March 29, 2023.

 

 

The ‘Lazarus’ drug

 

Naloxone is an opioid antagonist that is used to reverse known or suspected overdose. Overdose presents as respiratory or nervous system depression, and the nasal spray acts within 2 to 3 minutes.

Narcan (naloxone hydrochloride) nasal spray [package insert]. Radnor, PA: Adapt Pharma, Inc. November 2015.

 

First approved by the FDA in 1971, naloxone nasal spray comes as a palm-sized device, the tip of which is inserted into a person’s nose before the plunger is pressed. 

In discussing the role of the spray, the AMA states that, with overdose, the chance of opioid exposure is high—even with drugs mixed with fentanyl, such as cocaine or xylazine. Thus it’s always a good idea to administer naloxone in these circumstances.

Lubell J. Narcan lands OTC approval: What it means for patients, doctors. AMA. May 12, 2023.

 

 

The package insert instructs that, with overdoses involving partial agonists or mixed antagonists/agonists such as buprenorphine and pentazocine, larger or repeat doses may be required.

The drug can also trigger severe opioid withdrawal symptoms or result in cardiovascular events—especially in those with pre-existing disease. Adverse effects of the medication include hypertension, musculoskeletal pain, and headache, as well as nasal dryness, congestion, inflammation, and edema.

 

Advising patients on use

 

In an interview posted on the AMA’s website, Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, offered advice on how to educate patients on naloxone’s use. He advised that physicians talk with their patients about the risk of overdose, as well as review opioid and medication history before prescribing anything.

Patients should be informed that naloxone is now OTC, and instructed on how to administer the medication to someone who may have overdosed. The AMA offers the following video on administration.

 

Concerns over access

 

Despite now being available OTC, naloxone nasal spray may not be accessible to everyone. A main concern about access relates to price.

FDA Commissioner Robert M. Califf, MD, addressed price in the press release announcing the drug’s approval: “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need. [The] approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.” 

The drug’s manufacturer, Emergent, plans to make the product nationally available at retailers and online by late summer 2023.

Emergent’s Statement on Over-the-Counter Access, Availability and Pricing of NARCAN® Naloxone HCl Nasal Spray 4 mg. Emergent. April 2023.

 

 

Access will depend on price and maintaining or improving current distribution channels to underserved communities, along with securing coverage from insurers and Medicare. 

“Since there are a variety of factors associated with determining the OTC price, it is critical that we come together with government leaders, retailers and other key stakeholders to ensure efforts are focused on increasing awareness, broadening access, and helping to maintain affordability,” Emergent wrote.

The company added: “As such, we are actively working with retailers on pricing, access, and availability. A goal for the out-of-pocket retailer price is to be consistent with our public interest pricing for one carton of two 4 mg doses, although retail price is set by individual retailers. Our pricing for both public interest groups and retailers would be significantly less than the current Wholesale Acquisition Cost (WAC) price of $125.” 

The AMA is on board with a wide roll-out of OTC naloxone, and hopes to see it stocked in chain pharmacies, supermarkets, convenience stores, vending machines, supermarkets, and gas stations by the summer. Nevertheless, price is still of high concern, with price gouging viewed as unconscionable. 

Even at around $50, Dr. Mukkamala considered the price “prohibitive for a lot of people.” 

“We strongly encourage that the price of this medication when it becomes over-the-counter become something that's affordable. It's inexcusable for manufacturers, honestly, to price their products to maximize profits over saving these 100,000-plus lives,” he said.